Potential Toxic Compound Exposure Risk from Hemodialysis Machines

5/6/22 — The FDA issued a Letter to Healthcare Providers to share information about the potential risk of exposure to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs) and NDL polychlorinated biphenyls (PCBs) when using the following hemodialysis machines manufactured by Fresenius Medical Care: the 2008T, 2008K2, and 2008K models. The 2008K2 and 2008K models are no longer manufactured but may still be in clinical use.

The source of the NDL PCBAs and NDL PCBs is from the silicone tubing used as a part of the hydraulics in the machine and the dialysate lines. Although the tubing for the dialysate lines does not directly contact the blood, there is the potential for back filtering through the dialyzer into the patient’s blood circulation during treatment. Read more.